局限期SCLC超分割比常规分割放化疗疗效及安全性Meta分析

目的 系统评价放化疗治疗局限期SCLC时超分割与常规分割不同放疗模式有效性及安全性差异。方法 计算机检索Pubmed、Embase、Cochrane Library、Web of Science、中国生物医学文献数据库、万方、中国知网和维普等数据库,查找超分割对比常规分割放化疗治疗局限期SCLC的临床对照研究文献。使用Revman 5.3统计软件对近期疗效、生存资料及不良反应进行Meta分析。结果 纳入8篇临床对照研究文献,共计1 361例患者。Meta分析结果显示,超分割组与常规分割组有着相似的客观缓解率(OR=1.31,95%CI为 0.64~2.69,P=0.46);两组间2、5年OS率相近(RR=1.10,95%CI为 0.98~1.24,P=0.12;RR=1.13,95%CI为 0.75~1.69,P=0.56);超分割组的≥2级放射性食管炎发生率较常规分割组高(RR=1.74,95%CI为 1.39~2.17,P<0.05),但两组间≥2级的放射性肺炎(RR=0.73,95%CI:0.24~2.24,P=0.58)、>3级血液学毒性(RR=1.18,95%CI为 0.99~1.39,P=0.06)发生率相近。结论 在局限期SCLC放化疗中两种放疗分割模式的近期疗效与生存获益相当,但超分割放疗的放射性食管炎发生率较高。超分割放疗并未带来较常规分割放疗更多的优越性。     

大分割同期放化疗对局限期SCLC临床价值的Meta分析

目的:应用Meta分析评估大分割同期放化疗在局限期小细胞肺癌(limited disease small-cell lung cancer,LD-SCLC)中的价值。方法:检索中国生物医学文献数据库、中国学术期刊全文数据库、Cochrane Library、PubMed、Medline、Web of science、Embase 国内外数据库有关局部局限期SCLC患者大分割同期放化疗与常规分割/超分割同期放化疗对比的文献,依据入选和排除标准收集各项研究的近期疗效及生存情况，应用Meta分析方法评价大分割同期放化疗的临床疗效。结果:纳入符合标准的国内外文献5篇，共包括837例患者。大分割放疗与常规或超分割放疗相比，无进展生存时间相似(P=0.95)；大分割放疗可延长局限期小细胞肺癌患者的总生存期(P=0.03)；同时，大分割放疗不增加急性放射性食管炎和肺炎的发生率（RR=0.95，95%CI:0.63~1.42，P=0.79；RR=0.77，95%CI:0.39~1.51，P=0.44）。结论:大分割较常规分割/超分割同步放化疗延长总生存时间，不增加毒性，可作为局限期小细胞肺癌治疗的选择模式。     

早期乳腺癌保乳术后大分割放疗的Meta分析

目的:评价早期乳腺癌保乳术后大分割放射治疗(HOFRT)的疗效及安全性。方法:计算机检索PubMed、Cochrane Library、SCI、EMBASE、中文科技期刊全文数据库、中国期刊全文数据库、数字化期刊全文数据库和中国生物医学文献数据库,并辅以手工检索和其他检索。纳入比较早期乳腺癌保乳术后大分割放疗与常规放射治疗(CRT)的临床对照试验,根据Cochrane系统评价手册5.0.0质量评价标准进行质量评价,使用RevMan5.2软件进行Meta分析。结果:共纳入5个研究(8010例),Meta分析显示:与CRT相比,HOFRT后3年总生存率有差异［RR=1.03（95%CI:1.01-1.06）］,而5、10年总生存率方面无差异［RR=1.02（95%CI:0.99-1.06）、RR=1.02（95%CI:0.95-1.09）］;5年绝对美容满意率、无复发生存率及无病生存率方面无差异［RR=1.05（95%CI:0.95-1.16）、RR=0.97(95% CI:0.41-1.10)、RR=1.00(95%CI:0.95-1.05)］;5年局部复发率、腋窝及锁骨上窝复发率、对侧乳腺癌、第二肿瘤发生率及远处转移率无差异［RR=0.91(95%CI:0.69-1.19)、RR=0.87（95%CI:0.53-1.44)、RR=0.71(95%CI:0.43-1.15)、RR=0.87(95%CI:0.59-1.29)、RR=0.88(95%CI:0.58-1.34)］;5年1级、2级以上放射性皮炎发生率无差异［RR=0.74(95%CI:0.52-1.06)、RR=0.94(95%CI:0.46-1.96)］;5、10年乳房萎缩、乳房硬化及乳房水肿发生率,Meta分析结果分别为RR=0.91(95%CI:0.58-1.43)、RR=0.87(95%CI:0.79-0.96),RR=0.87(95%CI:0.74-1.02)、RR=0.88 (95%CI:0.78-1.00),RR=0.64(95%CI:0.51-0.79)、RR=0.65(95%CI:0.52-0.81),即HOFRT与CRT后5年乳房萎缩及5、10年乳房硬化发生率无统计学差异（P=0.69、P=0.08、P=0.05）,10年乳房萎缩及5、10年乳房水肿的发生率有统计学差异（P＜0.0001、P=0.005、P=0.0001）;5年肋骨骨折、肺纤维化及缺血性心脏病的发生率无差异［RR=1.04(95%CI:0.62-1.75)、RR=1.14(95%CI:0.64-2.03)、RR=0.71(95%CI:0.43-1.18)］;5、10年手臂水肿、毛细血管扩张及肩膀僵硬的发生率,Meta分析结果分别为RR=0.67(95%CI:0.36-1.23)、RR=0.67(95%CI:0.26-1.68)、RR=0.61(95%CI:0.41-0.91),RR=0.72(95%CI:0.56-0.95)、RR=0.94(95%CI:0.46-1.91)、RR=0.70(95%CI:0.42-1.15),即HOFRT与CRT后5、10年手臂水肿、肩膀僵硬的发生率无统计学差异（P=0.19、P=0.39,P=0.86、P=0.16）,HOFRT与CRT后5、10年毛细血管扩张的发生率有统计学差异（P=0.01、P=0.02）。结论:与CRT相比,HOFRT组3年生存率较好,10年乳房萎缩及5、10年乳房水肿的发生率及5、10年毛细血管扩张的发生率低,而在3、5、10年无复发生存率、无病生存率、局部复发率、对侧乳腺癌发生率、第二肿瘤的发生率及远处转移率等方面差异无统计学意义。HOFRT是一种可行的治疗方式,明显缩短了疗程,可减轻不良反应发生率,提高了患者的生活质量。由于纳入的研究数量较少且选择入组条件严格,今后尚需要开展高质量的随机对照试验以作进一步的论证。     

艾迪联合紫杉醇和顺铂治疗晚期非小细胞肺癌的meta分析

背景与目的 艾迪联合紫杉醇和顺铂(paclitaxel and cisplatin,TP)治疗晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)在临床疗效和安全性方面是否优于单用紫杉醇和顺铂存在着争议.本研究系统评价艾迪联合TP化疗方案治疗晚期NSCLC的临床疗效和安全性.方法 计算机检索Cochrane Library、Pubmed、EMBASE、CancerLit、中国生物医学文献数据库、中国期刊全文数据库、中文科技期刊全文数据库,检索时间从各数据库建库至2010年3月20日;同时辅助其它检索,纳入艾迪联合TP化疗方案治疗NSCLC的随机对照试验(randomized controlled trials,RCTs).两名评价者独立评价纳入研究的质量并提取资料,并用RevMan 5.0软件进行统计分析.结果 共纳入11篇RCTs,meta分析结果显示:与单纯TP化疗方案相比,艾迪注射液联合TP化疗方案可以改善近期疗效(RR=1.27,95%CI:1.10.1.47,P=0.001)、提高生活质量(RR=1.85,95%CI:1.54-2.21,P＜0.001)、减少白细胞下降(RR=0.71,95%CI:0.57-0.87,P=0.001)和血小板下降(RR=0.59,95%CI:0.40-0.87,P=0.008),降低恶心呕吐等胃肠道反应(RR=0.75,95%CI:0.58-0.98,P=0.03),而在血红蛋白下降(RR=0.97,95%CI:0.70-1.34,P=0.85)、肝功能下降(RR=0.63,95%CI:0.09-1.57,P=0.18)、肾功能下降(RR=0.42,95%CI:0.14-1.24,P=0.12)、周围神经炎发生情况(RR=0.86,95%CI:0.56-1.32,P=0.50)和脱发(RR=0.92,95%CI:0.63-1.34,P=0.66)方面的差异无统计学意义.结论 艾迪注射液联合TP方案可提高NSCLC治疗的近期疗效和患者生活质量、改善骨髓抑制,并降低化疗所产生的不良反应,值得临床推广使用.     

GP方案联合三维适形放疗同步治疗局部晚期非小细胞肺癌

目的探讨GP方案联合三维适形放疗同步治疗局部晚期非小细胞肺癌（NSCLC）的近期疗效和毒副反应。方法 30例局部晚期NSCLC患者采用GP方案联合三维适形放疗同步治疗。结果 30例患者均完成治疗计划,肺原发灶及纵隔转移淋巴结总有效率分别为83.4%和88.5%;毒副反应主要是骨髓抑制,胃肠道反应,轻中度放射性食管炎、放射性肺炎。结论 GP方案联合三维适形放疗同步治疗局部晚期NSCLC具有较好近期疗效及耐受性。     

EGFR-TKIs与化疗比较一线治疗非小细胞肺癌疗效的meta分析

背景与目的表皮因子受体酪氨酸激酶抑制剂(epidermal growth factor receptor tyrosine kinase inhibitor,EGFR-TKI)应用于非小细胞肺癌(non-small cell lung cancer,NSCLC)一线治疗取得较好的临床疗效,然而EGFR-TKI一线用药选择仍面临很多问题。本研究应用循证医学的方法对NSCLC患者临床特征及基因突变情况对一线EGFRTKIs治疗及化疗获益进行分析,以便指导临床用药。方法用计算机检索Pubmed、Embase、American Society of Clinical Oncology(ASCO)、European Society for Medical Oncology(ESCO)及生物医学数据库等数据库,寻找出EGFR-TKI与化疗相比一线治疗NSCLC的疗效的随机对照研究(randomized controlled trials,RCT)。对纳入RCT进行资料提取和质量评价,采用Review Manager 5.2软件分析、对比NSCLC患者在TKI治疗中的疗效。结果纳入的14项研究,共5,000例患者。Meta分析结果显示,EGFR基因突变的NSCLC患者,EGFR-TKIs治疗与化疗相比有较好的近期有效率(RR=2.31;95%CI:1.88-2.84)和延长无疾病进展时间(progression free survival,PFS)(HR=0.39;95%CI:0.30-0.49),总生存时间(overall survival,OS)上两者无明显差异(HR=0.99;95%CI:0.84-1.16)。临床选择(亚裔、腺癌、不吸烟)NSCLC患者,EGFR-TKIs一线治疗与化疗相比也有较好的近期有效率(RR=1.30;95%CI:1.15-1.47),PFS和OS无差异(HR=0.93;95%CI:0.58-1.49)(HR=0.91;95%CI:0.81-1.02)。未经选择的患者,一线EGFR-TKIs治疗有效率、PFS与化疗无差异,但OS劣于一线接受化疗患者。结论 EGFR突变的NSCLC患者一线EGFR-TKIs获益更多;对于不能耐受化疗的亚裔、腺癌、不吸烟患者,推荐一线EGFR-TKIs治疗;未经选择的NSCLC患者一线EGFR-TKIs治疗临床无获益,而且一线EGFR-TKI治疗的OS明显低于一线化疗。     

中高危局限期前列腺癌大分割及常规分割放疗疗效对比——Meta分析

目的 比较中高危局限期前列腺癌大分割放疗与常规分割放疗的疗效、不良反应的差异。方法 通过计算机检索国内外相关数据库,搜集有关中高危局限期前列腺癌大分割放疗及常规分割放疗比较的临床对照研究资料,采用Stata12.0软件进行分析。两组间差异采用HR和RR及95%CI描述。结果 根据纳入排除和标准,最终纳入5项包括1621例患者的临床对照研究资料。Meta分析结果显示两组OS率(HR=1.00,95%CI为0.85-1.17,P=0.980)和生化失败结果(RR=0.87,95%CI为0.68-1.12,P=0.274)均相似。与常规分割放疗比较,大分割放疗组≥2级急性胃肠反应发生率偏高(RR=1.94,95%CI为1.23-3.06,P=0.004)。两组≥2级急性泌尿系统不良反应(RR=1.03,95%CI为0.92-1.14,P=0.626),晚期≥2级胃肠(RR=1.17,95%CI为0.90-1.51,P=0.238)和泌尿系统(RR=1.11,95%CI为0.94-1.30,P=0.228)不良反应均相似(P值均>0.05)。结论 中高危局限期前列腺癌大分割放疗与常规分割放疗疗效相当,虽然大分割放疗组急性胃肠反应发生率略高于常规分割组,但两组晚期胃肠和泌尿系统反应并无差异,患者可耐受。     

局部晚期非小细胞肺癌适形调强放疗联合多西他赛同步化疗的临床观察

目的:探讨适形调强放疗联合多西他赛对局部晚期非小细胞肺癌(NSCLC)的疗效及不良反应。方法:将65例NSCLC患者,随机分为A组(35例)和B组(30例)。A组35例,采用适形调强放疗联合多西他赛和顺铂同步化疗,放疗后再予以多西他赛及顺铂化疗2个周期;B组30例,采用适形调强放疗结束后,予以多西他赛和顺铂化疗4～6个周期。结果:A组和B组有效率(RR)分别为82.9%和60.0%,两组比较差异有统计学意义,P=0.04;A组1和2年生存率分别为77.1%和48.6%,B组1和2年生存率分别为73.3%和43.3%,两组差异无统计学意义,P=0.63;A组和B组白细胞降低发生率分别为77.1%和53.3%(P=0.123),放射性食管炎分别为65.7%和53.3%(P=0.582),放射性肺炎分别为45.7%和40.0%,P=0.898。结论:适形调强放疗联合多西他赛同步化疗在近期疗效上优于序贯化疗,在不良反应上无差别。     

痰热清注射液治疗放射性肺炎的系统评价

目的:评价痰热清治疗放射性肺炎的有效性及安全性。方法:检索2000年1月-2011年1月中国期刊全文数据库、中国生物医学文献数据库、维普和万方数据库等。由两位研究者独立提取资料和进行质量评价,采用RevMan5.0软件进行统计分析。结果:共纳入11个研究,776例患者。Meta分析结果显示:痰热清联合抗生素和激素组与抗生素联合激素组相比,两组显效有统计学意义,RR(95%CI)为1.43(1.03,1.99),P=0.04,痊愈,有效两组间无统计学意义,RR(95%CI)分别为1.20(0.68,2.09),P=0.53,0.79(0.50,1.24),P=0.30;痰热清组与抗生素联合激素组相比,痊愈、有效指标间有统计学意义,RR(95%CI)分别为2.75(1.56,4.86),P=0.0005、1.36(1.08,1.72),P=0.009,显效两组间无统计学意义,RR(95%CI)分别为1.28(0.95,1.74),P=0.11;痰热清联合抗生素组与抗生素联合激素组相比,痊愈、显效指标间有统计学意义,RR(95%CI)分别为2.41(1.46,3.98),P=0.0006、1.67(1.16,2.40),P=0.006,有效两组间无统计学意义,RR(95%CI)为0.73(0.43,1.24),P=0.25,客观指标退热天数、止咳天数、痰色变化天数各指标间有统计学意义,RR(95%CI)分别为-1.10(-2.03,-0.18),P=0.02、-1.15(-1.77,-0.53),P=0.0003、-0.83(-1.53,-0.14),P=0.02。结论:痰热清联合抗生素和激素治疗放射性肺炎的临床疗效明显,痰热清单独应用在有效率,痊愈率方面也显示出一定的优势,与抗生素联用可提高抗生素的临床疗效,增加治愈率,改善患者症状,缩短退热时间,且不良反应发生率低。     

肿瘤骨转移治疗的系统评价

背景与目的骨转移是晚期恶性肿瘤常见并发症之一。本研究系统评价放疗联合静脉双膦酸盐与单纯放疗治疗肿瘤骨转移的临床疗效和安全性。方法计算机检索Cochrane图书馆、PubMed、EMBASE、CBM、CNKI和VIP等数据库,手工检索相关中文期刊,查阅纳入文献的参考文献,按照Cochrane系统评价方法评价纳入研究的质量,采用RevMan5.0软件进行统计分析。结果共纳入22项研究,1585例病例。meta分析结果显示:放疗联合静脉双膦酸盐疗法在疼痛控制总有效率(RR=1.21,95%CI:1.13-1.30,P0.001)、平均缓解时间(WMD=16.00,95%CI:10.12-21.88,P0.001)、病灶控制率(RR=1.69,95%CI:1.43-1.99,P0.001)和生活质量改善总有效率(RR=1.25,95%CI:1.08-1.45,P=0.003)方面优于单纯放疗。在不良反应方面,除放疗联合静脉双膦酸盐疗法发热高于单纯放疗外(RR=5.61,95%CI:3.11-10.13,P0.001),在恶心呕吐发生率(RR=1.15,95%CI:0.62-2.13,P=0.65)和骨髓抑制发生率(RR=1.23,95%CI:0.75-2.02,P=0.40)方面差异无统计学意义。结论放疗联合静脉双膦酸盐可快速、有效并长效控制骨转移性疼痛,有效提高肿瘤患者的活动能力及生活质量。     

Amifostine reduces side effects and improves complete response rate during radiotherapy: results of a meta-analysis

PURPOSE: To evaluate the efficacy of amifostine in diminishing radiotherapy side effects and whether or not it protects the tumor. METHODS AND MATERIALS: We performed a systematic review and meta-analysis of 14 included randomized controlled trials, comprising 1451 patients, comparing the use of radiotherapy vs. radiotherapy plus amifostine for cancer treatment. RESULTS: The use of amifostine significantly reduced the risk of developing mucositis (odds ratio [OR], 0.37; 95% confidence interval [CI], 0.29-0.48; p < 0.00001), esophagitis (OR, 0.38; CI, 0.26-0.54; p < 0.00001), acute xerostomia (OR, 0.24; CI, 0.15-0.36; p < 0.00001), late xerostomia (OR, 0.33; CI, 0.21-0.51; p < 0.00001), dysphagia (OR, 0.26; CI, 0.07-0.92; p = 0.04), acute pneumonitis (OR, 0.15; CI, 0.07-0.31; p < 0.00001) and cystitis (OR, 0.17; CI, 0.09-0.32; p < 0.00001). There was no difference in overall response rate between the groups. However, complete response rate was superior for patients using amifostine (OR, 1.81; CI, 1.10-2.96; p = 0.02). CONCLUSIONS: This systematic review shows that amifostine significantly reduces the side effects of radiation therapy. The efficacy of radiotherapy was not itself affected by the use of this drug and patients receiving amifostine were able to achieve higher rates of complete response.     

Effect of amifostine on toxicities associated with radiochemotherapy in patients with locally advanced non-small-cell lung cancer

PURPOSE: Radiochemotherapy (RCT) is an effective treatment for locally advanced non-small-cell lung cancer (NSCLC), but can be limited by acute and late toxicities (esophagitis, pneumonitis, and myelosuppression). This trial investigated whether pretreatment with amifostine, a radioprotector, could reduce the incidence of radiochemotherapy-induced acute and late toxicities. METHODS AND MATERIALS: Between October 1997 and August 1999, 73 patients with previously untreated Stage IIIa-IIIb NSCLC were randomized to treatment with RCT alone (n = 36) or RCT plus amifostine (300 mg/m(2) daily i.v. infusion, n = 37). RCT consisted of either paclitaxel (60 mg/m(2)) or carboplatin (AUC 2) once weekly during a 5- to 6-week course of conventional radiotherapy given as 2 Gy/5 days/week to a total dose of 55 to 60 Gy. Blood cell counts were measured weekly; esophagitis and acute lung toxicity were evaluated during the treatment course. Treatment efficacy was assessed following World Health Organization criteria for response. Late lung toxicity was assessed at 3 and 6 months after RCT and was graded from 0 to 4 according to the Radiation Therapy Oncology Group/European Organization for the Research and Treatment of Cancer criteria. RESULTS: A total of 68 patients were evaluable for toxicity analysis (RCT group, n = 32; RCT + amifostine, n = 36). There was no significant difference between treatment arms in patient baseline characteristics. The incidence of Grade >or=3 esophagitis during RCT was significantly lower for patients receiving amifostine than for patients receiving RCT alone (38.9% vs. 84.4%%, p < 0.001). Furthermore, the incidence of Grade >or=3 acute pulmonary toxicity was significantly reduced in patients treated with RCT plus amifostine compared to patients who received RCT alone (19.4% vs. 56.3%, p = 0.002). At 3 months after RCT, patients treated with amifostine had a significantly lower incidence of pneumonitis than patients who received RCT alone (p = 0.009). Combined response rates (complete plus partial responses) were 82.2% in the RCT group and 88.8% in the RCT plus amifostine group (p = 0.498).Amifostine is effective in reducing the incidence of both acute and late toxicities associated with RCT in patients with locally advanced NSCLC without compromising antitumor efficacy.     

Comparison of the Efficacy and Safety of EFGR TyrosineKinase Inhibitor Monotherapy with Standard Second-line Chemotherapy in Previously Treated Advanced Non-small-cell Lung Cancer: a Systematic Review and Meta-analysis

Purpose: To compare the efficacy and safety of epidermal growth factor receptor tyrosine kinaseinhibitormonotherapy (EFGR-TKIs: gefitinib or erlotinib) with standard second-line chemotherapy (single agentdocetaxel or pemetrexed) in previously treated advanced non-small-cell lung cancer (NSCLC). Methods: Wesystematically searched for randomized clinical trials that compared EGFR-TKI monotherapy with standardsecond-line chemotherapy in previously treated advanced NSCLC. The end points were overall survival (OS),progression-free survival (PFS), overall response rate (ORR), 1-year survival rate (1-year SR) and grade 3 or 4toxicities. The pooled hazard ratio (HR) or risk ratio (RR), with their corresponding 95% confidence intervals(CI) were calculated employing fixed- or random-effects models depending on the heterogeneity of the includedtrials. Results: Eight randomized controlled trials (totally 3218 patients) were eligible. Our meta-analysis resultsshowed that EGFR-TKIs were comparable to standard second-line chemotherapy for advanced NSCLC interms of overall survival (HR 1.00, 95%CI 0.92-1.10; p=0.943), progression-free survival (HR 0.90, 95%CI0.75-1.08, P=0.258) and 1-year-survival rate (RR 0.97, 95%CI 0.87-1.08, P=0.619), and the overall responserate was higher in patients who receiving EGFR-TKIs(RR 1.50, 95%CI 1.22-1.83, P=0.000). Sub-group analysisdemonstrated that EGFR-TKI monotherapy significantly improved PFS (HR 0.73, 95%CI: 0.55-0.97, p=0.03)and ORR (RR 1.96, 95%CI: 1.46-2.63, p=0.000) in East Asian patients, but it did not translate into increase in OSand 1-year SR. Furthermore, there were fewer incidences of grade 3 or 4 neutropenia, febrile neutropenia andneutrotoxicity in EGFR-TKI monotherapy group, excluding grade 3 or 4 rash. Conclusion: Both interventions hadcomparable efficacy as second-line treatments for patients with advanced NSCLC, and EGFR-TKI monotherapywas associated with less toxicity and better tolerability. Moreover, our data also demonstrated that EGFRTKImonotherapytended to be more effective in East Asian patients in terms of PFS and ORR compared withstandard second-line chemotherapy. These results should help inform decisions about patient management anddesign of future trials.     

甘氨双唑钠对非小细胞肺癌放射治疗增敏作用的Meta分析

背景与目的甘氨双唑钠对非小细胞肺癌(non-small cell lung cancer,NSCLC)放射增敏作用的疗效和安全性目前并没有明确的证据,本研究系统评价甘氨双唑钠对NSCLC放射治疗增敏作用的临床疗效和安全性,为临床实践与更深入研究提供参考。方法计算机检索Cochrane Library、PubMed、EMbase、中国生物医学文献数据库、中国学术期刊全文数据库、中国科技期刊数据库和数字化期刊全文数据库,同时辅助其它检索,收集所有关于甘氨双唑钠对NSCLC放射治疗增敏作用的随机对照试验(randomized controlled trial,RCT)。参考Cochrane质量评价标准进行质量评价,并利用RevMan5.1软件进行统计学分析。结果共纳入21个RCT,Meta分析结果显示,甘氨双唑钠联合放疗的近期疗效优于单纯放疗疗法(OR合并=3.29,95%CI:2.47-4.39,P<0.000,01)或优于放疗联合安慰剂(维生素C)疗法(OR合并=3.65,95%CI:2.25-5.92,P<0.000,01);在生存质量提高率和1年、2年生存率方面两组差异均无统计学意义(P>0.05);在放射性肺炎、放射性食管炎、血液学毒性、心脏毒性等安全指标方面两组差异均无统计学意义(P>0.05)。结论甘氨双唑钠联合放疗疗法治疗NSCLC,近期疗效优于单纯放疗或放疗联合安慰剂(维生素C)疗法,并且不增加放疗不良反应,值得临床推广使用。     

Effect of amifostine on response rates in locally advanced non-small-cell lung cancer patients treated on randomized controlled trials: a meta-analysis

PURPOSE: Amifostine can reduce the cytotoxic effects of chemotherapy and radiotherapy in patients with locally advanced non-small-cell lung cancer, but concerns remain regarding its possible tumor-protective effects. Studies with sufficient statistical power to address this question are lacking. METHODS AND MATERIALS: We performed a meta-analysis of all published clinical trials involving locally advanced non-small-cell lung cancer patients treated with radiotherapy with or without chemotherapy, who had been randomized to treatment with amifostine vs. no amifostine or placebo. Random effects estimates of the relative risk of overall, partial, and complete response were obtained. RESULTS: Seven randomized trials involving 601 patients were identified. Response rate data were available for six studies (552 patients). The pooled relative risk (RR) estimate was 1.07 (95% confidence interval, 0.97-1.18; p = 0.18), 1.21 (95% confidence interval, 0.83-1.78; p = 0.33), and 0.99 (95% confidence interval, 0.78-1.26; p = 0.95) for overall, complete, and partial response, respectively (a RR >1 indicates improvement in response with amifostine compared with the control arm). The results were similar after sensitivity analyses. No evidence was found of treatment effect heterogeneity across the studies. CONCLUSIONS: Amifostine has no effect on tumor response in patients with locally advanced non-small-cell lung cancer treated with radiotherapy with or without chemotherapy.     

立体定向体部放疗联合或不联合化疗治疗≥5 cm的非小细胞肺癌的临床疗效及不良反应

目的:比较立体定向体部放疗（stereotactic body radiotherapy,SBRT）联合或不联合化疗治疗≥5 cm的非小细胞肺癌的临床疗效及不良反应。方法:回顾性分析于我院接受SBRT的68例非小细胞肺癌患者。所有肿瘤最大直径≥5 cm且无淋巴结及远处转移。A组26例患者接受个体化SBRT联合顺铂为基础的化疗,B组42例患者接受单独的个体化SBRT治疗。χ2分析比较两组有效率及不良反应,Kaplan-Meier绘制生存曲线。结果:A组有效率高于B组(73.08% vs 66.67%),两者之间无统计学差异(P=0.86)。所有患者中位OS为29个月（8~92个月）,A组患者中位OS为29个月(8~92个月),B组患者中位OS为20个月(9~90个月)。Kaplan-Meier生存分析显示两组有统计学差异(P=0.03)。Cox回归分析显示是否化疗为OS的独立影响因素(HR=0.37;95%CI=0.15~0.92;P=0.03)。A组血液学毒性明显多于B组(P=0.001),全身不良反应(疲劳和厌食)多于B组(P=0.01),A组放射性食管炎及放射性肺炎患者比例高于B组(分别为65.38% vs 59.52%,69.23% vs 61.9%),但两组间无统计学差异(P=0.87和P=0.52)。结论:SBRT应用于直径≥5 cm的非小细胞肺癌可得到较佳的临床疗效,无严重不良反应。SBRT联合化疗可在不明显增加不良反应的情况下延长患者生存期。仍需前瞻性、大规模的临床试验进一步证实。     

全脑放疗时间对EGFR突变非小细胞肺癌脑转移患者生存的影响

背景与目的全脑放疗（whole brain radiotherapy, WBRT）在表皮生长因子受体（epidermal growth factor receptor,EGFR）突变的非小细胞肺癌（non-small cell lung cancer, NSCLC）脑转移患者治疗中何时应用尚无高级别的循证医学证据。本研究旨在探讨WBRT的参与时间对携有EGFR突变的NSCLC脑转移患者生存的影响。方法2009年8月-2015年5月在我院确诊的EGFR突变伴脑转移的晚期NSCLC共78例患者,均接受WBRT及EGFR酪氨酸激酶抑制剂（EGFR tyrosine kinase inhibitors, EGFR-TKIs）治疗的48例初治患者进入临床分析,采用Cox比例风险模型分析患者颅内无进展生存期（progression-free survival, PFS）及总生存期（overall survival, OS）的影响因素。结果全组患者颅内客观缓解率（objective response rate, ORR）为81.3%,颅内疾病控制率（disease control rate, DCR）为93.8%,中位颅内PFS为10个月,中位OS为18个月。颅内PFS的多因素分析显示,美国东部肿瘤协作组评分（Eastern Cooperative Oncology Group performance status, ECOG PS）0分-1分（HR=30.436,95%CI：4.721-196.211,P<0.001）及早期WBRT患者（HR=3.663,95%CI：1.657-8.098,P=0.001）的颅内PFS更佳。OS的多因素分析显示,ECOG PS 0分-1分（HR=57.607,95%CI：6.135-540.953,P<0.001）、早期WBRT（HR=2.757,95%CI：1.140-6.669,P=0.024）及立体定向放射外科（stereotaxic radio surgery, SRS）的应用（HR=5.964,95%CI：1.895-18.767,P=0.002）是患者OS的独立预后因素。结论早期WBRT联合TKIs治疗可改善EGFR突变的NSCLC脑转移患者的预后,尚有待大样本的前瞻性临床试验验证。     

重组人血管内皮抑素联合化疗与单纯化疗在晚期非小细胞肺癌中疗效比较的系统评价

背景与目的近年来已有大量有关抗血管生成药物重组人血管内皮抑素(恩度,rh-endostatin)在肺癌治疗中有效性和安全性的研究与报道,真实评价重组人血管内皮抑素对肺癌的治疗效果具有重要意义,本文将系统评价重组人血管内皮抑素联合化疗与单纯化疗在晚期非小细胞肺癌(non-small cell lung cancer,NSCLC)治疗中的疗效与安全性。方法采用Cochrane系统评价方法,对Embase、Medline、SCI、Cochrane图书馆、中国生物医学文献数据库、中文科技期刊全文数据库、中国期刊全文数据库等数据库进行计算机检索,检索时间截止至2010年3月。纳入标准为研究对象为晚期NSCLC病例,实验组为重组人血管内皮抑素联合化疗,对照组为单独使用化疗,研究内容为比较两组治疗疗效的随机对照试验。纳入研究的质量由两名研究者评估。采用RevMan5.0软件对研究进行meta分析。结果按照标准共纳入15篇文献,1,326例病例。15项研究均为临床随机对照试验,其中2项对随机方法进行了详细描述,13项未对盲法进行描述。Meta分析表明,长春瑞滨+顺铂+重组人血管内皮抑素方案(NPE)与长春瑞滨+顺铂方案(NP)比较反应率差异有统计学意义(OR=2.16,95%CI:1.57-2.99),NPE方案治疗后重度白细胞减少(OR=0.94,95%CI:0.66-1.32)、重度血小板下降(OR=1.00,95%CI:0.64-1.57)和恶心呕吐(OR=0.85,95%CI:0.61-1.20)发生率均与NP方案比较无显著性差异(P>0.05)。NPE+放疗方案与NP+放疗方案的反应率相似(OR=2.39,95%CI:0.99-5.79),NPE+放疗方案治疗后白细胞减少(OR=0.83,95%CI:0.35-1.94)、血小板下降(OR=0.78,95%CI:0.19-3.16)和放射性食管炎(OR=1.00,95%CI:0.40-2.49)发生率均与NP+放疗方案比较无显著性差异(P>0.05)。结论在晚期NSCLC的治疗中,重组人血管内皮抑素与以铂类为基础的化疗方案联用可提高治疗反应率,同时毒副作用增加不明显,但在此基础上再与放疗联用并不能提高治疗反应率。由于本文纳入的研究较少,发生偏倚可能性较大,从而影响到结论的论证强度,尚需更多高质量的双盲随机对照研究提供证据。